Dry Eyeanti-VEGFNCT06710951
Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface in Intravitreal Injections of Anti-VEGF
A study testing Change of normal concentration of povidone-iodine 5% to 1% in people with Dry Eye, run by José Gerardo García Aguirre at 1 site in Mexico.
Trial summary
Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Change of normal concentration of povidone-iodine 5% to 1%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteMexico
- Study dates
- 15 Nov 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having anti-VGEF intravitreal injection scheduled
- Informed consent signed
Who cannot join
- Under 45 years
- Opacity that prevents ophthalmological evaluation and fixation
- Patients with severe dry eye
- Patients with signs of infection on the ocular surface
- Allergy to iodine
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en México I.A.P.
Mexico City, Mexico City, 04030
About this study
Official title: Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface As Antiseptic for Anti Vascular Endothelial Growth Factor Intravitreal Injections
Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection
Read the detailed description
Randomized, prospective clinical trial. One group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-VEGF intravitreal injection. Each patient was evaluated before and after the injection of anti-VEGF for tear break up time, bulbar redness and ocular surface satining with fluorescein. Pain perception was also evaluated 15 minutes after the injection and 48 hours after.
- Conditions
- Dry Eye
- Being tested
- Change of normal concentration of povidone-iodine 5% to 1%
- Keywords
- Povidone-iodine, Pain
- Medical subject headings
- Dry Eye Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of normal concentration of povidone-iodine 5% to 1%Procedure or surgery
Normal concentration of povidone-iodine during anti-VEGF intravitreal injection was 5%. That concentration was utilized in the control group, and 1% in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Povidone-iodine 1% | Experimental | Povidone-iodine 1% was used as antiseptic during anti-VEGF intravitreal injection Receives: Procedure: Change of normal concentration of povidone-iodine 5% to 1% |
| Povidone-iodine 5% | Active comparator | Povidone-iodine 5% was used as antiseptic during anti-VEGF intravitreal injection Receives: Procedure: Change of normal concentration of povidone-iodine 5% to 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear breaking rupture
NIKBUT was measured with Keratopgraph before and after intravitreal injection
Measured: Change from baseline measured to 15 minutes post-injection
Bulbar redness
Bulbar redness was measured with Keratopgraph before and after intravitreal injection
Measured: Change from baseline measured to 15 minutes post-injection
Secondary outcomes (2)
Oxford scale
Oxford scale was measured with fluorescein stain before and after intravitreal injection
Measured: Change from baseline measured to 15 minutes post-injection
Pain analog scale
Pain using visual analog scale was measured 15 minutes and 48 hours after intravitreal injection
Measured: Change from baseline measured to 15 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start15 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical, prospective, randomized trial. Pre anti-VEGF intravitreal injection, with OCULUS Keratopgrapph 5M topograph, non invasive tear breaking time, bulbar redness, and Oxford scale with fluorescein staining were measured. During anti-VEGF injection, tetracaíne was use as anestetic. Povidone-iodine 1% or 5% was randomized as antiseptic. After anti-VEGF intravitreal injection, patients were examined again for tear bkreaking time, bulbar redness and Oxford sacle, plus pain 15 minutes after injection. Finally, two days after the injection, patients were interviwed by telephone about their pain.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- José Gerardo García Aguirre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José Gerardo García Aguirre, Asociación para Evitar la Ceguera en México
- Investigators
- José Gerardo García-Aguirre, Principal investigator, Asociación para Evitar la Ceguera en México I.A.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710951
- Sponsor's protocol ID
- RE-21-02
- Acronym
- anti-VEGF
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface As Antiseptic for Anti Vascular Endothelial Growth Factor Intravitreal Injections
- ClinicalTrials.gov ID
- NCT06710951
- Acronym / sponsor ID
- anti-VEGF / RE-21-02
- Conditions
- Dry Eye
- Keywords
- Povidone-iodine, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- José Gerardo García AguirreUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection
Detailed description
Randomized, prospective clinical trial. One group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-VEGF intravitreal injection. Each patient was evaluated before and after the injection of anti-VEGF for tear break up time, bulbar redness and ocular surface satining with fluorescein. Pain perception was also evaluated 15 minutes after the injection and 48 hours after.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clinical, prospective, randomized trial. Pre anti-VEGF intravitreal injection, with OCULUS Keratopgrapph 5M topograph, non invasive tear breaking time, bulbar redness, and Oxford scale with fluorescein staining were measured. During anti-VEGF injection, tetracaíne was use as anestetic. Povidone-iodine 1% or 5% was randomized as antiseptic. After anti-VEGF intravitreal injection, patients were examined again for tear bkreaking time, bulbar redness and Oxford sacle, plus pain 15 minutes after injection. Finally, two days after the injection, patients were interviwed by telephone about their pain.
| Arm | Type | Receives |
|---|---|---|
| Povidone-iodine 1% | Experimental | Procedure: Change of normal concentration of povidone-iodine 5% to 1%Povidone-iodine 1% was used as antiseptic during anti-VEGF intravitreal injection |
| Povidone-iodine 5% | Active comparator | Procedure: Change of normal concentration of povidone-iodine 5% to 1%Povidone-iodine 5% was used as antiseptic during anti-VEGF intravitreal injection |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having anti-VGEF intravitreal injection scheduled
- Informed consent signed
Key exclusion criteria (6 listed)
- Under 45 years
- Opacity that prevents ophthalmological evaluation and fixation
- Patients with severe dry eye
- Patients with signs of infection on the ocular surface
- Allergy to iodine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change of normal concentration of povidone-iodine 5% to 1%Normal concentration of povidone-iodine during anti-VEGF intravitreal injection was 5%. That concentration was utilized in the control group, and 1% in the experimental group. | Procedure or surgery | Povidone-iodine 1%, Povidone-iodine 5% |
Primary outcome
Tear breaking rupture
Time frame: Change from baseline measured to 15 minutes post-injection
NIKBUT was measured with Keratopgraph before and after intravitreal injection
Bulbar redness
Time frame: Change from baseline measured to 15 minutes post-injection
Bulbar redness was measured with Keratopgraph before and after intravitreal injection
2 secondary outcomes
Oxford scale
Time frame: Change from baseline measured to 15 minutes post-injection
Pain analog scale
Time frame: Change from baseline measured to 15 minutes post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Gerardo García-Aguirre principal investigator
Asociación para Evitar la Ceguera en México I.A.P.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change of normal concentration of povidone-iodine 5% to 1% in people with Dry Eye, run by José Gerardo García Aguirre at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear breaking rupture (time frame: Change from baseline measured to 15 minutes post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.